MD2Me - Texting to Promote Chronic Disease Management

Cystic Fibrosis Clinical Trial

Official title:

TAHLC - Texting to Promote Adolescent Health Liaisons and Chronic Disease Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01253733
• Other study ID #: 091146
• Status: Completed
• Phase: N/A
• First received: November 30, 2010
• Last updated: January 25, 2016
• Start date: October 2009
• Est. completion date: March 2012

Study information

• Verified date: January 2016
• Source: Huang, Jeannie, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

UCSD researchers are conducting a study aimed to develop and evaluate a chronic disease self management web and text message based program on health-related self-efficacy and frequency of adolescent-conducted healthcare interactions. We hypothesize that users of the program will demonstrate greater gains between baseline and 8 month measures of health related self-efficacy and adolescent-conducted healthcare interactions as compared to the usual care comparison group.

Description:

The MD2Me study (or also known as TAHLC), sponsored by the National Institutes of Health is a 2-year randomized controlled trial to develop and test a text message and Internet based intervention among adolescents and young adults with cystic fibrosis, type 1 diabetes, or inflammatory bowel disease. Adolescents and young adults have been a difficult population to engage in healthcare. It is estimated that 1 in 5 adolescents do not get the healthcare they need. Interventions must address how the healthcare system can engage adolescents with chronic disease and provide opportunities to discuss health-related matters and improve disease outcomes.

This study will help fill multiple gaps in the literature by exploring the utility of a push AND pull SMS texting-based application for chronic disease management among youth. Based on social cognitive theory, the intervention will use accessible technology to promote disease management among adolescents with chronic disease as they transition to adult care. The popularity and usage of SMS already demonstrated by adolescents suggests notable promise for the SMS-based TAHLC program to promote chronic disease self-management and healthcare engagement with substantial positive impacts on health among youth with chronic disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 22 Years

Eligibility

Inclusion Criteria:

• ages 14 - 22 years

• have cystic fibrosis, type 1 diabetes, or inflammatory bowel disease for at least 6 months

• have access to the internet

• speak English

• has a parent that speaks English or Spanish (if primary participant is under 18)

• willingness to attend assessment visits

Exclusion Criteria:

• pregnant or have children

• have a history of substance abuse or other psychiatric disorder that would impair compliance with study protocol

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Disease Management
• Cystic Fibrosis
• Diabetes Mellitus, Type 1
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Type 1 Diabetes

Intervention

Behavioral:
• MD2ME
The goals of the MD2Me intervention include increasing disease self-efficacy, disease knowledge, and the ability to control one's disease independently. The intervention includes an 8-week web program with weekly behavioral skills, topics on how to navigate the healthcare system, lifestyle tips, a Discussion Board, and text messages.

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
Huang, Jeannie, M.D.	University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (1)

Huang JS, Terrones L, Tompane T, Dillon L, Pian M, Gottschalk M, Norman GJ, Bartholomew LK. Preparing adolescents with chronic disease for transition to adult care: a technology program. Pediatrics. 2014 Jun;133(6):e1639-46. doi: 10.1542/peds.2013-2830. Epub 2014 May 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related self-efficacy	The primary aim of the study will be to develop and test the effect of a texting intervention TAHLC on health-related self-efficacy and frequency of adolescent-conducted healthcare interactions over the study period of 8 months.	8 months	No
Secondary	Health knowledge	Disease health knowledge	8 months	No
Secondary	Health literacy	Health literacy	8 months	No
Secondary	Quality of Life	Quality of life including depression, self-esteem, and social support will be assessed.	8 Months	No